Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost

Not Applicable

Recruiting

• Conditions: Food Insecurity
• Interventions: Other: Product prescription program- NutriConnect Credit; Other: Product prescription program- NutriConnect Delivery

• Registration Number: NCT06263751
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost.

Detailed Description

The Produce Prescription Program, as one type of Food is Medicine (FIM) initiatives, involves healthcare providers prescribing fruits and vegetables to patients often have low incomes, food insecurity, and diet-related illnesses. Previous systematic reviews have shown that these programs are associated with increased consumption of fruits and vegetables, improved diet quality, reduced food insecurity, and better management of diet-related diseases. However, the diversity in study designs, small sample sizes, and varied intervention intensities have limited the conclusive understanding of the full effects of these programs. Despite their potential benefits, critical gaps persist, notably in identifying the most effective strategies for socioeconomically disadvantaged patients. Additionally, challenges surrounding scalability, implementation, and sustainability hinder the widespread adoption of these programs.

To address these gaps, the NutriConnect team employs a Designing for Dissemination and Sustainability (D4DS) approach informed by the PRISM/RE-AIM framework. This involves early engagement of key partners crucial for scalability and sustainability. The study team initiated a collaborative consortium comprising Washington University in St. Louis, BJC Healthcare, and Schnucks (regional grocery chain). NutriConnect integrates multilevel, multicomponent intervention components, including in-hospital social needs screening, produce prescription, grocery rewards, and a health and wellness program, all aimed at promoting better nutrition and health in the community. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on fruits and vegetables intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes, with the following aims.

Aim 1. Evaluate and compare the effectiveness of NutriConnect Credit with NutriConnect Delivery on changes in fruit and vegetable intake, food security, and self-reported health status.

Aim 2. Explore the scalability, sustainability, and determinants of the NutriConnect program guided by PRISM/RE-AIM, aiming to identify factors crucial for future scale-up.

Aim 3. Determine the implementation costs of NutriConnect using time-driven activity-based costing approach.

Study Timeline

• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-16
• Status Verified: 2024-03
• Study Start: 2024-03-25
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Adults (>= 18 years)
2. Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home.
3. Being screened positive for food or financial insecurity.
4. Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.

Exclusion Criteria

1. Does not have competence to provide informed consent.
2. Is under suicide watch.
3. Is in police custody.
4. In hospice or palliative care.
5. Not have a stable home.
6. Is pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NutriConnect Credit	Product prescription program- NutriConnect Credit	Patient is given $20 credit to their Schnucks (grocery) Reward account every other week for F\&V shopping.
NutriConnect Delivery	Product prescription program- NutriConnect Delivery	Patient receives produce (F\&V) box (with equivalent $20 value) delivered to home every other week.

Primary Outcome Measures

Name	Time	Method
change in F&V intake	6-month	pre- and post-changes in F\&V consumption (cups/day, continuous).

Secondary Outcome Measures

Name	Time	Method
Household food insecurity	6-month	pre- and post-changes in household food insecurity (binary). 6-item USDA Food Security Survey, minimum value = 0, maximum value = 6, lower the score means higher the food security

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States